NCT05330871

Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.

A Single Center, Open-label, Parallel Controlled, Randomized Phase II Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV-IM, Ad5-nCoV-IH or Inactivated COVID-19 Vaccine in Population 6 to 17 Years of Age

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Seventh Medical Center of PLA General Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, parallel controlled, and randomized Phase II clinical trial to evaluate the safety and immunogenicity of two types of Recombinant Novel Corona Virus Vaccine (Adenovirus type 5 vector) in population aged 6-17 years who have been previously immunized with 2 doses of inactivated COVID-19 vaccine. This is to evaluate the safety and immunogenicity of different heterologous prime-boost regimen in this population.

Detailed description

Participants will be randomized into two age groups: children aged 6-12 years and adolescents aged 13-17 years. Subjects who have previously been immunized with 2 doses of inactivated COVID-19 vaccine will be randomized into the booster dose groups to receive either 1 dose of 0.1ml inhaled Ad5- nCoV-IH, 1 dose of 0.3ml intramuscular Ad5-nCoV-IM or 1 dose of 0.5ml intramuscular inactivated vaccine ICV as activecomparator in a ratio of 3:1:1. Participants who have not received any COVID-19 vaccine previously will be randomized into 2 primary dose age groups: children aged 6-12 years and adolescents aged 13-17 years to receive 2 doses of 0.1ml inhaled Ad5-nCoVIH. The first 5 subjects of each age group will enter the sentinel group to receive Ad5-nCoV-IH and monitor for safety before the rest of the enrollment process.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	1 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	2 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	3 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	4 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	5 Intramuscular injection for booster groups	Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL	6 Intramuscular injection for booster groups	Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL	7 Intramuscular injection for booster groups	Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL	8 Intramuscular injection for booster groups	ICV, 1 dose 0.5ml
BIOLOGICAL	9 Intramuscular injection for booster groups	ICV, 1 dose 0.5ml
BIOLOGICAL	10 Intramuscular injection for booster groups	1 dose 0.5ml
BIOLOGICAL	11 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	12 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	13 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	14 Nebulized inhalation for booster groups	Ad5-nCoV-IH, 1 dose 0.1ml
BIOLOGICAL	15 Intramuscular injection for booster groups	Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL	16 Intramuscular injection for booster groups	Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL	17 Intramuscular injection for booster groups	Ad5-nCoV-IM, 1 dose 0.3ml
BIOLOGICAL	18 Intramuscular injection for booster groups	ICV, 1 dose 0.5ml
BIOLOGICAL	19 Intramuscular injection for booster groups	ICV, 1 dose 0.5ml
BIOLOGICAL	20 Intramuscular injection for booster groups	ICV, 1 dose 0.5ml
BIOLOGICAL	21 Nebulized inhalation for primary groups	Ad5-nCoV-IH, 2 doses 0.1ml
BIOLOGICAL	22 Nebulized inhalation for primary groups	Ad5-nCoV-IH, 2 doses 0.1ml
BIOLOGICAL	23 Nebulized inhalation for primary groups	Ad5-nCoV-IH, 2 doses 0.1ml
BIOLOGICAL	24 Nebulized inhalation for primary groups	Ad5-nCoV-IH, 2 doses 0.1ml

Timeline

• Start date: 2022-04-17
• Primary completion: 2022-06-30
• Completion: 2023-05-30
• First posted: 2022-04-15
• Last updated: 2023-04-13

Locations

1 site across 1 country: China